Intracranial aneurysms
Conditions
Interventions
Case series:Tubridge flow-diverter is used to treat the intracranial aneurysms
Sponsors
Henan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged 18 or older, male or non-pregnant; 2. DSA/CTA/MRA diagnose patients with unruptured aneurysms of internal carotid artery or vertebral artery (including cystic, fusiform and dissecting aneurysms) with the aneurysm neck <=20mm; 3. The patient and/or his/her authorizer understand the purpose of the study, participate voluntarily and sign the informed consent; 4. The researchers consider that patients could be treated with flow diverters; 5. Patients willing to be followed up for evaluation as required by the clinical study protocol.
Exclusion criteria
Exclusion criteria: 1. Patients who have had a stent or coil placed at the lesion within 3 months; 2. Patients who have had or planned major surgery within 30 days; 3. Aneurysm is related to intracranial arteriovenous malformation(AVM); 4. The researchers consider the patients are not suitable for vascular interventional therapy, such as no suitable, vascular access, internal carotid or aortic dissection are possible, intracranial vasculitis is possible, intracranial vessels are excessively tortuous, vessels with severe narrowing or previous incomplete dilatated stents prevents the devices from reaching the lesion or patients with previous vasospasm and poor anticonvulsant effect. 5. Tubridge contraindicated patients, such as patients with antiplatelet or anticoagulant therapy contraindications, patients with DSA contraindications, including (1) Iodine contrast agent allergy or intolerance; (2) Interventional device allergy; (3) Severe cardiac, hepatic and renal insufficiency; (4) Partial infection of the puncture site; (5) Cerebral hernia, patients with allergy to Nitinol and patients with active infection(body temperature above 38 degree C or white blood cell count > 15*10^9/L); 6. Participants in other clinical trials of drugs or medical devices; 7. The clinical status is extremely poor, and the score of modified Rankin Scale (mRS) >=5; 8. Patients with a life expectancy of less than 12 months; 9. Female who are breast-feeding or plan to become pregnant during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The complete aneurysm occlusion rate 12 months after the surgery (Raymond I); | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgical technique success rate;Successful occlusion rate of target aneurysm 12 months after surgery (Raymond I and II);The incidence of significant stenosis of the parent artery (> 50% stenosis) 12 months after surgery;Incidence of aneurysma-related disabling stroke or neurogenic death during follow-up;Changes of modified Rankin Scale (mRS) before and 6 months after surgery;All-cause mortality during follow-up;Target aneurysm retreatment rate during the follow-up period; | — |
Countries
China
Contacts
Public ContactTianxiao Li
Henan Provincial People's Hospital
Outcome results
None listed